James Mathew
Oshawa
Summary
A clinical research professional with extensive experience in pharmacy and education, currently seeking a role in a forward-thinking organization. Proficient in conducting clinical trials with adherence to global standards and regulatory guidelines, including ICH-GCP. Skilled in safe and efficient execution of trial protocols, reporting, and documentation. Holds advanced certifications in clinical research and a strong background in pharmacy practice and academic coordination.
Professional with experience in clinical research coordination, equipped to make significant impact in this field. Demonstrated ability to manage clinical trials, ensure compliance with protocols, and maintain accurate documentation. Strong emphasis on team collaboration, reliability, and adaptability to evolving project requirements. Proficient in patient recruitment, data collection, and regulatory submissions, with results-driven approach that ensures successful study outcomes.
Overview
23
23
years of professional experience
Work History
Clinical Research Coordinator 1 (volunteer)
BioPharma Services Inc.
10.2024 - Current
- Coordinating conduct of the clinical trials at BPSI.Primarily the type of trials assigned will be standard Bioequivalence studies.This includes but is not limited to:
- With assistance lead clinical aspects (excluding recruiting) of assigned Bioequivalence trials
- Act as the point of contact for the clinical group for assigned trials when dealing with internal and external customers
- Preparation of study related documentation
- Review completion of study documents (Case Report Forms and Source Documents)
- Perform clinical and study procedures as per study protocol as training and experience allows
- Detailed review of subject and study documentation, case report form (CRFs) and source documents
- Ensure the conduct of clinical trials according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and BioPharma Services Inc
- Standard Operating Procedures (SOPs) at all times
- Work with the QA group during Audits and Audit Follow-up and in the development/revision and implementation of Standard Operating for the Bioequivalence trials; ensure that the SOPs are consistent with GCP, and regulatory guidelines; review and update SOPs as required
- Responsible for remaining current with regulatory requirements (TPD, FDA, etc.)
- Participate in staff training sessions
- Other duties as may be required and as training and experience allow
Pharmacy Assistant
Wal-Mart Pharmacy
08.2008 - 03.2024
- Assisted customers with prescription refills, requests for over-the-counter medications and other health care products
- Resolved customer complaints promptly in a professional manner
- Adhered to all legal requirements relating to the safe dispensing of medication
- Completed daily paperwork associated with filling prescriptions accurately
- Managed inventory levels of medications and supplies
- Provided guidance on the selection of over-the-counter medications and supplements
- Maintained inventory records by restocking shelves with pharmaceuticals
- Received telephone calls from physicians, nurses or other healthcare professionals requesting information about medications or supplies
- Verified accuracy of medication orders and entered data into pharmacy system
Senior Lecturer, Course Coordinator in Pharmacy
Master Skill University College of Health Science, Malaysia
08.2006 - 01.2008
- Mentored new faculty members on best practices for teaching at a university level
- Conducted lectures, tutorials, seminars, workshops and laboratory classes for undergraduate and graduate students
- Maintained accurate records of student attendance and grades throughout the semester
- Provided guidance and mentorship to junior lecturers on curriculum development
- Assisted in developing new courses based on current trends in the field of study
- Evaluated student progress through assessments such as quizzes, exams, presentations, projects and reports
- Advised students on their professional development paths by providing resources or connections with potential employers
- Conducted regular assessment of student performance through assignments, tests, and examinations to monitor progress and provide timely feedback
- Taught courses in Hospital and Clinical Pharmacy, emphasizing the integration of clinical research in pharmaceutical education
Senior Lecturer
Devakai Amma Memorial College Of Pharmacy India
05.2005 - 08.2006
- Advised students on their professional development paths by providing resources or connections with potential employers
- Created syllabus outlines for each class according to departmental guidelines
- Collaborated with other departments across campus to create interdisciplinary courses that foster creative problem solving skills among students
- Reviewed student assignments and examinations in order to assess performance levels
Staff Pharmacist
Thengana Medical Mission Hospital and Research Center
01.2002 - 08.2003
- Compounded and dispensed medications, and managed inventory control with a focus on accuracy and regulatory compliance
- Managed the filling and dispensing of prescriptions in accordance with established policies and procedures
- Provided medication counseling to patients on proper use, side effects and potential drug interactions
- Assisted with inventory control processes such as ordering supplies, reconciling invoices
Education
Post Graduate Diploma - Clinical Research
Oxford College
02.2025
Master Of Pharmacy - Pharmacy Practice
Annamalai University
01.2005
Post Graduate Diploma - Hospital Management
Annamalai University
01.2003
Bachelor Of Pharmacy -
Rajiv Gandhi University Of Health Sciences
01.2002
Bachelor of Science -
Mahatma Gandhi University
01.1996
Skills
- Good clinical practices
- Electronic data capture
- Documentation management
- Informed consent
- Adverse event reporting
- Study protocols
- Informed consent process
- Data analysis
- Patient recruitment
- Documentation requirements
- Trial management
- Clinical trial management
- Records maintenance
Training
- Good Clinical Practice (GCP), 2024
- Good Documentation Practice (GDP), 2024
- WHMIS, 2024
- 21 CFR Part 11 Training, 2024
- Fire Safety Training, 2024
- Health and Safety Online Training, 2024
- Privacy Act (PIPEDA), 2024
- Phlebotomy and Venipuncture, 2024
- Intramuscular Injection, 2024
- Advanced ICH GCP Certification (AGCPC), 2024
- Advanced Clinical Trial Assistant Certification (ACTAC), 2024
- Good Clinical Practice, 2024
- Ethical Conduct for Research Involving Humans (TCPS), 2024
- First Aid, CPR and BLS, 2024
Publications
A Hospital Based study on some Clinico-Epidemiological aspect of Bronchopneumonia among infants and young children., C. K. Dhanapal, James Mathew, S. Madhusudhan, R. Manavalan, International journal of chemical Sciences, 1, 1, 11/01/09, 107-112
Languages
English
Full Professional
Timeline
Clinical Research Coordinator 1 (volunteer)
BioPharma Services Inc.
10.2024 - Current
Pharmacy Assistant
Wal-Mart Pharmacy
08.2008 - 03.2024
Senior Lecturer, Course Coordinator in Pharmacy
Master Skill University College of Health Science, Malaysia
08.2006 - 01.2008
Senior Lecturer
Devakai Amma Memorial College Of Pharmacy India
05.2005 - 08.2006
Staff Pharmacist
Thengana Medical Mission Hospital and Research Center
01.2002 - 08.2003
Post Graduate Diploma - Clinical Research
Oxford College
Master Of Pharmacy - Pharmacy Practice
Annamalai University
Post Graduate Diploma - Hospital Management
Annamalai University
Bachelor Of Pharmacy -
Rajiv Gandhi University Of Health Sciences
Bachelor of Science -
Mahatma Gandhi University
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